Cold medicines not for toddlers

FDA warns of risk to kids under age 2

August 16, 2007|By GARDINER HARRIS The New York Times

WASHINGTON — Hoping to prevent a growing number of injuries to infants and toddlers, the Food and Drug Administration issued an advisory Wednesday warning parents never to give cough and cold medicines to children under the age of 2 unless instructed to do so by a doctor.

The warning is part of a broad reassessment by the agency of the safety of the popular medicines, which have been blamed for hundreds of injuries and a few of deaths in children under the age of 2.

The FDA will convene a panel of independent experts Oct. 18 to discuss whether more prohibitions or warnings are warranted. Such meetings often signal that the agency is seriously concerned about the safety of the drugs under review.

The drugs' labels currently advise parents to see a doctor before giving the medicines if their child is younger than 2, but too many parents are failing to heed this advice, the agency said.

"We continue to see adverse effects associated with the medicines because people are not using them properly," said Susan Cruzan, an FDA spokeswoman.

If, despite label warnings, parents continue to use the drugs inappropriately in young children, the agency could take more serious action, like restricting the drugs' wide availability. Most drugs that have been withdrawn in the past 15 years were taken off the market because doctors and patients failed to heed prominent warnings.

Some prominent pediatricians and public health experts said that the agency's advisory did not go far enough. One group petitioned the agency to ban the marketing of the drugs to children younger than 6, and some said that the medicines should no longer be sold over-the-counter for use by children at all.

But the drugs' makers said that the FDA approved the drugs because they were safe and effective. Virginia Cox, a spokeswoman for the Consumer Healthcare Products Association, said that the drugs' labels already advised against their use in children younger than 2 unless a doctor approved. Cox said there was no need to raise this age limit to 6.

The debate has arisen because the standards for drug approvals have changed sharply in the decades since many of the medicines in children's cough and cold products were approved. If those drugs were presently up for review, they would not be approved for use in children because the manufacturers never tested them thoroughly in children.

Instead, the drugs' makers performed studies in adults and then simply assumed that they would work in children. Such assumptions, once common, are no longer acceptable. Indeed, a growing number of studies in children suggest that cough and cold medicines work no better than placebos.

Some of the injuries and deaths associated with these products have resulted when parents gave two different products to their child, not realizing that both contained identical medicines, resulting in an overdose.